# FDA 483 - Luminex Corporation - October 22, 2021

Source: https://www.keypedia.com/records/483/luminex-corporation/269aaf2d-c120-43cc-a6a8-ed91fe724725

> FDA 483 for Luminex Corporation on October 22, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Luminex Corporation
- Inspection Date: 2021-10-22
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Luminex Corporation in Northbrook, IL, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm failed to adequately establish servicing procedures, report device removals posing health risks to the FDA, and maintain effective corrective and preventive action procedures. Several issues were repeat observations from prior inspections and a Warning Letter, indicating a persistent lack of compliance.

## Related Documents

- [483 - 2020-02-14](https://www.keypedia.com/records/483/luminex-corporation/221264e9-df77-4e42-b781-44d51e5e60a4)
- [WARNING_LETTER - 2020-02-14](https://www.keypedia.com/records/warning_letter/luminex-corporation/02b42ede-af22-4ce1-ba03-0e0f48ac82d3)
- [EIR - 2023-01-20](https://www.keypedia.com/records/eir/luminex-corporation/da1d5c99-6d34-4f55-9d5f-57544e9bef7a)
- [483 - 2023-01-20](https://www.keypedia.com/records/483/luminex-corporation/28d8ccac-6815-4b4b-9fa0-23d265e28e06)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.keypedia.com/companies/luminex-corporation/55525767-0124-4f84-8e09-0a8d7b03947e

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669